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President Barack Obama on Sept. 15 nominated Robert Califf as the next FDA commissioner, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More
CDER Director Janet Woodcock came under fire Sept. 17 from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More
Legislation to avoid a federal government shutdown cleared an important procedural hurdle in the Senate on Monday, as lawmakers voted 77 to 19 to end debate on a stopgap funding bill to extend current spending levels until Dec. 11. Read More
The European Commission has approved Sanofi and Regeneron’s bad cholesterol treatment Praluent, two months after it was cleared by the FDA for the U.S. market. Read More
Novo Nordisk expects to launch its once daily insulin Tresiba in the first quarter of 2016, following FDA approval of that and another diabetes treatment on Friday. Read More
The FDA is seeking feedback on a draft addendum to the International Conference on Harmonisation’s good clinical practice guideline aimed at streamlining approaches to trial design, conduct, oversight, recording and reporting. Read More
The U.S. Patent and Trademark Office has denied Celgene’s request to sanction a hedge fund owner for seeking to profit by challenging the validity of drug patents, saying there was nothing inherently wrong with the action. Read More